Induction of Labor in Nulliparous Women With an Unfavorable Cervix: A Randomized Controlled Trial Comparing Double and Single Balloon Catheters and PGE2 Gel (original) (raw)
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International Journal of Advanced Research (IJAR), 2019
Introduction:Induction of labour is an intervention after 28 weeks of gestation, intended to artificially initiate uterine contractions resulting in the progressive effacement and dilatation of the cervix and ending in vaginal delivery. Sometimes because of medical or obstetric complications of pregnancy, cervical ripening and induction of labour is often required. Induction of labour is indicated when the benefits to either the mother or fetus outweigh those of continuing the pregnancy [1]. Aim Of The Study:To compare efficacy and safety of intracervical Foley?s balloon catheter with intracervical prostaglandin E2 gel (dinoprostone) for induction of labour. Objectives:To compare cervical ripening, induction-delivery interval, mode of delivery, maternal complications and fetal outcome by two methods. Materials And Methods:Prospective randomized controlled study. SAMPLE SIZE- Each group 50, determined by statistical analysis. Successful induction considered if the patient entered the active phase of labour/ bishop score 6. Result:In present study, both groups were comparable in age distribution. In both the groups, most of the study subjects were between the age group of 18-25 years (76% in pgE2 v/s 70% in Foley?s catheter group). Mean age in PGE2 gel group was 23.20?3.03 years while Mean age in Intra-Cervical Foley?s Catheter group was 23.92?3.11 years. Mean gestational age in PGE2 gel group was 39.12?1.33 weeks compared to 39.06?1.18 weeks in Intra-Cervical Foley?s Catheter group. At start of induction mean Bishop score was 1.62?1.10 in PGE2 gel group while it was 1.58?1.01 in Intra-Cervical Foley?s Catheter group. Deshmukh V et al also reported similar pre-induction mean Bishop score (1.48?0.67 in Foley?s Catheter group v/s 1.59?0.59 in pgE2 gel group). In our study, post-induction mean Bishop score at 6 hours was 6.56?2.13 in PGE2 gel group while it was 4.70?2.21 in Intra-Cervical Foley?s Catheter group. Mean change in Bishop score between 0 to 6 hours was significantly higher in pgE2 gel group (4.94?1.78) compare to Foley?s catheter group (3.12?1.78). The rate of LSCS in pgE2 gel group was 10% and 32% in Foley?s catheter group respectively. The induction delivery interval showed significantly higher time in intracervical Foley?s catheter groups. The mean induction delivery internal was 13.80?3.83 hrs in Foley?s group and 9.65?2.13 hrs in PGE2 group. In our study, common maternal complication observed were Intrapartum pyrexia (1 case in pgE2 gel group and 8 cases in Foley?s catheter group) and puerperal pyrexia (1 case in pgE2 gel group and 4 cases in Foley?s catheter group). 1 case of hyperstimulation was also seen in pgE2 gel group. Apart from that we have not seen any other complication in mothers. The present study shows that the fetal outcome results were also comparable in both the groups. Conclusion:The results of this trial tended to favor the prostaglandins use over Foley catheter use. The main advantage of the PGE2 gel is that early ripening of cervix, lesser caesarean rate and infection rate as compared to the Foley?s catheter while disadvantage is higher chances of uterine hypertonicity or tachysystole. but Foley?s catheter mimicked the physiology of the labour onset more closely, resulting in a less likelihood of hyperstimulation, fetal heart rate abnormalities and postpartum hemorrhage. Now, there is recent trend of reintroducing the mechanical methods like the Foley catheter, as there is an availability of sterile devices, controlling one of the principal contraindications- infection. Such mechanical methods are advantageous in terms of their reversibility and the reduced expenditure. But Foley?s catheter has been linked with a possibility of infections in some larger studies. Thus, tremendous attention should be drawn towards carrying out aseptic measures while it is being inserted, to avoid maternal and probable neonatal infections.
Archives of Gynecology and Obstetrics, 2011
Purpose To compare the outcome of induced labor at term using sequential intracervical Foley catheter with intravaginal misoprostol versus intravaginal misoprostol alone. Methods A prospective matched case control study among parturient with prolonged pregnancy and unfavorable cervix at a tertiary hospital in Nigeria. Results The study population was 100 with a mean age of 29.46 ± 3.88 years. Parturient with prior cervical priming using intracervical Foley catheter had significantly lower oxytocin augmentation of uterine contractions in labor (44 vs. 64%, P = 0.045), shorter mean insertion to active phase labor duration (233 ± 98 vs. 354 ± 154 min, P = 0.0001), shorter insertion to delivery interval (514 ± 175 vs. 627 ± 268, P = 0.014), more vaginal delivery \12 h (92.5 vs. 60%, P = 0.001) and less delivery by caesarean section (20 vs. 40%, P = 0.029). Conclusions The sequential combination of intracervical Foley catheter and intravaginal misoprostol for cervical ripening and induction of labor appears to be a safe and more effective method compared to intravaginal misoprostol in parturient at term with unfavorable cervices.
BMC Pregnancy and Childbirth, 2013
Background: Induction of labour (IOL) is one of the commonest obstetric interventions, with significant impact on both the individual woman and health service delivery. Outpatient IOL is an attractive option to reduce these impacts. To date there is little data comparing outpatient and inpatient IOL methods, and potential safety concerns (hyperstimulation) if prostaglandins, the standard inpatient IOL medications, are used in the outpatient setting. The purpose of this study was to assess feasibility, clinical effectiveness and patient acceptability of outpatient Foley catheter (OPC) vs. inpatient vaginal PGE2 (IP) for induction of labour (IOL) at term. Methods: Women with an unfavourable cervix requiring IOL at term (N = 101) were randomised to outpatient care using Foley catheter (OPC, n = 50) or inpatient care using vaginal PGE2 (IP, n = 51). OPC group had Foley catheter inserted and were discharged overnight following a reassuring cardiotocograph. IP group received 2 mg/1 mg vaginal PGE2 if nulliparous or 1 mg/1 mg if multiparous. Main outcome measures were inpatient stay (prior to birth, in Birthing Unit, total), mode of birth, induction to delivery interval, adverse reactions and patient satisfaction. Results: OPC group had shorter hospital stay prior to birth (21.3 vs. 32.4 hrs, p < .001), IP were more likely to achieve vaginal birth within 12 hours of presenting to Birthing Unit (53% vs. 28%, p = .01). Vaginal birth rates (66% OPC Vs. 71% IP), total induction to delivery time (33.5 hrs vs. 31.3 hrs) and total inpatient times (96 hrs OPC Vs. 105 hrs IP) were similar. OPC group felt less pain (significant discomfort 26% Vs 58%, p = .003), and had more sleep (5.8 Vs 3.4 hours, p < .001), during cervical preparation, but were more likely to require oxytocin IOL (88 Vs 59%, p = .001). Conclusions: OPC was feasible and acceptable for IOL of women with an unfavourable cervix at term compared to IP, however did not show a statistically significant reduction in total inpatient stay and was associated with increased oxytocin IOL.
Acta Obstetricia et Gynecologica Scandinavica, 2019
IntroductionWhen women with a previous cesarean section and an unfavorable cervix have an indication for delivery, the choice is to induce labor or to perform a cesarean section. This study aims to assess the effectiveness and safety of a balloon catheter as a method of induction of labor in women with one previous cesarean section and an unfavorable cervix compared with an elective repeat cesarean section.Material and methodsWe performed a prospective cohort study in 51 hospitals in the Netherlands on term women with one previous cesarean section, a live singleton fetus in cephalic position, an unfavorable cervix and an indication for delivery. We recorded obstetric, maternal and neonatal characteristics. We compared the outcome of women who were induced with a balloon catheter with the outcome of women who delivered by elective repeat cesarean section. Main outcomes were maternal and neonatal morbidity. Mode of delivery was a secondary outcome for women who were induced. Adjusted ...
European Journal of Obstetrics & Gynecology and Reproductive Biology, 1994
with prostaglandin E, (PGE,) in vaginal pessaries. Study group: One-hundred and nine pregnant women with unfavourable cervices. Major outcome measures: The effkiency of inducing vaginal delivery and the level of 'disadvantages following induction of labour' (DisFIL scorings). Results: Overall, BCEAS was less efficient inducing vaginal delivery than vaginal PGEz (P < 0.01) because of a significant difference among parous women (P < 0.01). In the (larger) primiparous women group, and particularly in the subgroup of these having very low pelvic scores (Lange score, I 3), the efficiencies of the two methods were equal (P = 0.06) and P = 0.55, respectively). The levels of DisFIL scorings were not significantly different. However, higher rates of caesarean section followed BCEAS than PGE, (29% and 100/o, respectively; P < 0.05). Serious infectious complications were not recorded following BCEAS. No difference was apparent in the status of the neonates (judging from Apgar scores and umbilical artery pH and SBE). The women, delivering vaginally, commented the two methods equally favourably. Conclusion: BCEAS was less efficacious than vaginal PGE, pcssaries, though among primiparous women, especially those with very unfavourable cervices, the difference was not significant. Further refinements of the method are suggested.
Journal of Medical Science And clinical Research, 2017
Aim: To evaluate the efficacy of transcervical Foley catheter with extra amniotic saline infusion in cervical ripening before induction of labour with intravaginal prostaglandin E1. Methodology: 106 patients with cephalic presentation, singleton pregnancy with intact membranes having modified Bishop's score < /= 2 were selected. They were randomly divided in to two groups of 53 each. In group A Foley catheter with extra amniotic saline infusion was given for cervical ripening before the induction of labour with intravaginal PG E1 and in group B , PG E1 was given intravaginally without using Foley and extra amniotic saline infusion. Induction to delivery interval was calculated from the time when the intravaginal PG E1 is kept. Results: There was significant improvement in modified Bishop score after Foley catheter expulsion in group A. The mean induction to delivery interval was significantly shorter and rate of vaginal delivery within 24 hours was significantly higher when compared to group B. There was no significant difference in mode of delivery, intra partum complications, rate of ARM, oxytocin use or neonatal outcomes. Conclusion: Intra cervical Foley catheter with extra amniotic saline infusion is an effective method for cervical ripening in women with very unfavourable cervices.
Archives of Gynecology and Obstetrics, 2018
Purpose To analyze the effect of combined application of intravaginal PGE2 insert and intracervical Foley balloon catheter for induction of labor. Methods Patients with unfavorable cervices who required induction of labor from August 2017 to December 2017 were evaluated for the study. Three hundred and ten participants were randomly assigned to study (n:155) and control group (n:155). Nine patients in study group and seven patients in control group were excluded, because they declined to participate in the study. Totally, 294 women analyzed in this prospective randomized study: Group 1 (control group): labor induction with intravaginal PgE2 vaginal insert alone (n = 148) and Group 2 (study group): intracervical Foley balloon catheter insertion adjunct to the intravaginal PgE2 insert (n = 146). The primary outcome of our study was the period from induction to delivery. The secondary outcome was the period from induction to active phase of labor. Results In the analysis of primiparous pregnants, combination of intracervical Foley balloon catheter and intravaginal PgE2 insertion was shown to be associated with shorter duration from induction to active stage of labor (1000 vs. 585 min, P < 0.001) and also to delivery (1386 vs. 1001 min, P < 0.001). Groups were found to be similar in terms of duration from induction to active stage of labor (670.5 vs. 535.2, P > 0.05) and also to delivery (933.1 vs. 777.9, P > 0.05, Table 2) in subgroup of women with the previous vaginal delivery. Conclusions Combined application of intracervical Foley balloon catheter and intravaginal PgE2 insert may result in a shorter time from labor induction to delivery without rising the risk of cesarean section in primiparous women with an unfavorable cervix.